- Key contributor in Clinical Development strategy planning and present to various internal governance committees.
- Provide leadership and clinical oversight across all assigned studies and programs as the US Lung cancer team leader, have direct accountabilities to assigned clinical programs.
- Work with regulatory and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation.
- Support other functions and teams with clinical science information and input for regulatory submissions and other regulatory processes.
- Play a lead role in the development and implementation of communications strategies to support existing and completed studies including KOL interactions, advisory boards, major medical meetings, congresses and other events, publications and other materials.
- Contribute clinical science input into the relevant therapeutic/disease area scientific strategy.
- Identify strategic and incremental organizational resource needs re: People, Process and Technology.
- Plan and direct career development for US Lung Cancer team members
- Models values and Leadership Expectations, provide strong mentoring and coaching skills for team members.
- MD within a clinical and/or scientific profession (or an equivalent level of professional, clinical and/or scientific education, training and experience) required.
- 10 plus years of experience within other biotech/pharmaceutical or relevant academic credentials companies.
- Subspecialty training in hematology/oncology.
- Requires complex scientific knowledge and development expertise to translate an asset into a medicine.
- Able to facilitate and integrate strong science into commercially viable products.
- Effective scientific and team communication (written and verbal), interpersonal, organizational, and cross functional collaboration skills.
- Experience in managing study start-up, directing and guiding study team execution, data cleaning, medical review, database locks, managing health authority responses are also required.
- Identifies the need for and leads the team in developing strategies to achieve team objectives.
- Leads the team in leveraging all available resources and information to maximize the effectiveness of long- and short-range planning.
- Having direct accountability for driving clinical development programs and enjoy the accountability of working in a fast-paced, entrepreneurial environment.
- Able to build highly productive teams both cross-functionally and externally.
- Able to develop high potential team members into leadership positions.
- Develop strong cross-functional working relationships with a diverse team of senior leaders.
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Executive Director, Clinical Development, Solid Tumors - Emeryville, United States - BeiGene
Description
General Description:
The Executive Director, Clinical Development will effectively lead BeiGene clinical assets through successful development of early and late phase clinical development strategies and deliverables in partnership with multiple functions across the organization, and with external academicians and collaboration partners.
As a leader in the organization, the incumbent will be involved with asset and disease strategy and help assure that activities are executed within expected scope, budget, and timelines.
The incumbent will play a key role in the establishment and growth of Clinical Development team as the United States Lung Cancer team leader.
This leader must be a thoughtful and mentoring manager, responsible for hiring, training, developing, and retaining talent.
Specifically, the incumbent will collaborate with a variety of internal and external partners and stakeholders, such as clinical investigators, scientists and key opinion leaders (KOLs), as well as multidisciplinary internal groups, including other groups in Clinical Development, research, business development, commercial operations, legal, etc.
Key Roles & Responsibilities:
Required Education:
Qualifications Requirement:
Critical Experience
Program Management and Clinical Development Expertise
Team Leadership and Credibility
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
